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Assess the benefits of Beyaz and SAFYRAL and the risks of VTE before initiating therapy
Before initiating Beyaz and SAFYRAL in a new combination oral contraceptive (COC) user or a woman who is switching from a contraceptive that does not contain drospirenone (drsp®), consider the risks and benefits of a drsp-containing COC in light of her venous thromboembolism (VTE) risk (eg, smoking, obesity, family history of VTE).
Based on epidemiologic studies evaluating the relative risk of thromboembolism in women using COCs
- COCs containing drsp may be associated with a higher risk of VTE than those containing levonorgestrel or some other progestins
- Reported VTE risk in these studies ranged from no increase to a 3-fold increase for drsp-containing COCs
Counsel patients about the information regarding the risk of VTE with drsp-containing COCs compared to COCs that contain levonorgestrel or some other progestins.
Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) 3 mg/0.02 mg/0.451 mg and 0.451 mg, and SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) 3 mg/0.03 mg/0.451 mg and 0.451 mg, are indicated for women who choose an oral contraceptive for contraception for:
- Prevention of pregnancy
- 99% contraceptive efficacy when used as directed
- Raising folate levels for the purpose of reducing the risk of a neural tube defect (NTD) in a pregnancy conceived while taking the product or shortly after discontinuing the product
Beyaz is also indicated for women who choose an oral contraceptive for contraception for:
Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD)
- The effectiveness of Beyaz for PMDD when used for more than 3 menstrual cycles has not been evaluated. Beyaz has not been evaluated for the treatment of premenstrual syndrome (PMS)
- Treatment of moderate acne for women at least 14 years of age who have achieved menarche
Important Safety Information about BEYAZ and SAFYRAL
Patients who should not take BEYAZ or SAFYRAL
Women over 35 years old who smoke should not use BEYAZ or SAFYRAL. Smoking increases the risk of serious cardiovascular side effects from BEYAZ or SAFYRAL use. This risk increases with age and the number of cigarettes smoked.
- BEYAZ and SAFYRAL are contraindicated in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other hormone-sensitive cancer, liver tumors (benign or malignant) or liver disease, conditions that predispose to hyperkalemia (ie, renal impairment, hepatic dysfunction, and adrenal insufficiency), or who are pregnant
Know serious risks with BEYAZ and SAFYRAL
Thromboembolic and Other Vascular Events: Stop BEYAZ or SAFYRAL if an arterial or venous thrombotic event occurs. The risk of venous thromboembolism (VTE) is highest during the first year of combination oral contraceptive (COC) use. This increased risk is greatest after initially starting a COC or restarting the same or a different COC following a 4 week or greater Pill-free interval. Epidemiologic studies suggest drospirenone (drsp®)‐containing COCs may be associated with a higher risk of VTE than COCs containing levonorgestrel or some other progestins. These studies reported the risk of VTE ranged from no increase to a 3‐fold increase. Before initiating BEYAZ or SAFYRAL in a new COC user or in a woman switching from a contraceptive not containing drsp, consider the risks and benefits of BEYAZ or SAFYRAL in light of her VTE risk (eg, smoking, obesity, family history of VTE)
COC use also increases risk of arterial thromboses (eg, stroke and myocardial infarction), especially in women with risk factors for these events. Use COCs with caution in women with cardiovascular disease risk factors. If feasible, stop BEYAZ or SAFYRAL at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start BEYAZ or SAFYRAL no earlier than 4 weeks after delivery in women not breastfeeding
- Hyperkalemia: BEYAZ and SAFYRAL contain drospirenone that has the potential for hyperkalemia in high-risk patients and are contraindicated in patients with conditions that predispose to hyperkalemia. Check serum potassium level during the first treatment cycle in women who receive long-term treatment with medications that may increase serum potassium (eg, ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs). Consider monitoring serum potassium levels in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly such as azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g. indinavir, boceprevir) and clarithromycin.
- Liver Disease: Discontinue BEYAZ or SAFYRAL if jaundice develops
- High Blood Pressure (BP): Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. Monitor BP in women with well-controlled hypertension and stop BEYAZ or SAFYRAL if BP rises significantly. BP may increase in COC users, more likely occurring in older women and with extended use
- Gallbladder Disease: Studies suggest a small increased relative risk of developing gallbladder disease among COC users
- Carbohydrate and Lipid Metabolic Effects: Monitor prediabetic and diabetic COC users. Consider alternative contraception for women with uncontrolled dyslipidemia
- Headache: If a BEYAZ or SAFYRAL user develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue BEYAZ or SAFYRAL if indicated
- Bleeding Irregularities: Evaluate irregular bleeding or amenorrhea; check for causes such as pregnancy or malignancy
- For BEYAZ, folates may mask vitamin B12 deficiency
- Counsel patients that BEYAZ and SAFYRAL do not protect against HIV infection and other sexually transmitted diseases
Serious adverse reactions in clinical trials:
- Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma
Most common adverse reactions (≥2%) in clinical trials:
- In BEYAZ clinical trials: premenstrual syndrome (12.4%), headache/migraine (10.3%), breast pain/tenderness/discomfort (8.1%), nausea/vomiting (4.4%), mood changes (2.3%), and abdominal pain/discomfort/tenderness (2.2%)
- In SAFYRAL clinical trials: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), mood changes (2.3%), and abdominal pain/discomfort/tenderness (2.3%)
Drug interactions (see Prescribing Information of concomitant drugs)
- Effects of Other Drugs on COCs: Drugs or herbal products that induce certain enzymes (eg, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternate method of contraception during use and for 28 days following discontinuation of concomitant use. Certain drugs (eg, atorvastatin, moderate or strong CYP3A4 inhibitors, verapamil, macrolides, diltiazem) and grapefruit juice may increase plasma levels of the estrogen or the progestin or both. HIV/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors may increase or decrease plasma levels of COCs. There have been reports of pregnancy while taking hormonal contraceptives and antibiotics concomitantly
- Effects of COCs on Other Drugs: COCs may inhibit or induce metabolism of other drugs (eg, lamotrigine). Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with COC use
- Effects on Serum Potassium: See hyperkalemia information
- Effects of Folates on Other Drugs: Folates may decrease the pharmacological effect of certain antifolate drugs
- Effects of Other Drugs on Folates: Several drugs (eg, methotrexate and sulfasalazine, cholestyramine, certain antiepileptics) may reduce folate levels via various mechanisms
Natazia is indicated for use by women to prevent pregnancy.
Natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of birth control.
The contraceptive efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been evaluated.
Important Safety Information About Natazia
Women over 35 years old who smoke should not use Natazia. Smoking increases the risk of serious cardiovascular side effects from Natazia use. This risk increases with age and the number of cigarettes smoked.
Patients who should not take Natazia
Know the most serious risks
Serious adverse reactions in clinical trials
Most common adverse reactions (≥2%) in clinical trials
Please see full Prescribing Information for Natazia, including Boxed Warning.
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